Humira (adalimumab) Line(s) of Business: HMO; PPO; QUEST Integration. Original Effective Date: 10/01/2015 Current Effective Date: 03/01/201811/01/2018

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1 Humira (adalimumab) Line(s) of Business: HMO; PPO; QUEST Integration Original Effective Date: 10/01/2015 Current Effective Date: 03/01/201811/01/2018 POLICY A. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved Indications Moderately to severely active rheumatoid arthritis (RA) Moderately to severely active polyarticular juvenile idiopathic arthritis (pjia) Active psoriatic arthritis (PsA) Active ankylosing spondylitis (AS) Moderately to severely active Crohn s disease (CD) Moderate to severely active ulcerative colitis (UC) Moderate to severe chronic plaque psoriasis (PsO) Moderate to severe hidradenitis suppurativa Uveitis Compendial Uses Axial spondyloarthritis B. REQUIRED DOCUMENTATION The following information is necessary to initiate the prior authorization review: For psoriasis, the following documentation is required: o InitialFor new starts on therapy Documentation supporting a history of plaque psoriasis for longer than six months Percent of body surface area involvement Documentation of crucial body areas affected (e.g. hands, feet, face, neck, scalp, etc.) if present Results of treatment with methotrexate such as ineffective treatment or intolerance, or documentation that methotrexate is contraindicated o For ccontinuation of therapy, ddocumentation in member s chart or medical record supporting a decrease in percent of body surface area involvement when compared to baseline must be submitted

2 Humira 2 For Crohn s disease, prescribers will be asked to fill in the member s Crohn s Disease Activity Index (CDAI) at baseline and after 6 months of therapy

3 Humira 3 C. CRITERIA FOR INITIAL APPROVAL 1. Moderately to severely active rheumatoid arthritis (RA) Initial authorization of 6 months may be granted for members with RA who have tried a disease modifying anti-rheumatic drug (DMARD). 2. Moderately to severely active polyarticular juvenile idiopathic arthritis (pjia) Initial authorization of 6 months may be granted for members with active pjia who have tried a disease modifying anti-rheumatic drug (DMARD). 3. Active psoriatic arthritis (PsA) Initial authorization of 6 months may be granted for members who meet the following criteria: i. Member has been diagnosed with active PsA, and meets ANY of the following: a) Member experienced an inadequate response to methotrexate b) Member has a history of intolerance to methotrexate c) Member has a contraindication to methotrexate 4. Active ankylosing spondylitis (AS) and axial spondyloarthritis Initial authorization of 6 months may be granted for members with active AS/axial spondyloarthritis who meet ANY of the following criteria: i. Member has experienced an inadequate response to treatment with an NSAID over a 4- week period in total at the maximum recommended or tolerated anti-inflammatory dose ii. Member has experienced intolerance to NSAID therapy iii. Member has a contraindication to all NSAIDs 1.5. Moderately to severely active Crohn s disease (CD) Initial authorization for 6 months may be granted for members who meet allboth of the following criteria: i. Member has moderately to severely active CD i.ii. Member has a pre-treatment Crohn s Disease Activity Index (CDAI) score 220. ii.iii. Member has tried any of the following conventional therapies for CD: mesalamine, sulfasalazine, ciprofloxacin, metronidazole, azathioprine, mercaptopurine, methotrexate, methylprednisolone, or prednisone Moderately to severely active ulcerative colitis (UC) Initial authorization for 6 months may be granted for members who meet both of the following criteria: i. Member has moderately to severely active UC ii. Member has tried any of the following conventional therapies for UC: mesalamine, sulfasalazine, azathioprine, mercaptopurine, methylprednisolone, prednisone, cyclosporine, tacrolimus (or antibiotics for pouchitis only) Moderately to severely active rheumatoid arthritis (RA) Initial authorization of 6 months may be granted for members with RA who have tried a disease modifying anti-rheumatic drug (DMARD) Moderate to severe chronic plaque psoriasis Initial authorization of 6 months may be granted for members who meet ALL of the following criteria:

4 Humira 4 i. Treatment with Humira was recommended by a dermatologist ii. Member has been diagnosed with moderate to severe chronic plaque psoriasis defined as the following a) At least 10% of body surface area (BSA) is affected, or crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected, and b) History of psoriasis 6 months or longer iii. Plaque psoriasis is characterized by well-defined patches of red and raised skin iv. Member has tried methotrexate for at least 3 months at a therapeutic dose and found it to be ineffective, or the member exhibited intolerance or allergy, or the use of methotrexate is contraindicated. a) Ineffective treatment is defined as symptoms and/or signs that are not resolved after completion of treatment at the recommended therapeutic dose and duration. If there is no recommended treatment time, the member must have had a meaningful trial. b) Intolerance is defined as having a recognized and reproducible or repeated adverse reaction that is clearly associated with taking the medication. c) Allergy is defined as a state of hypersensitivity produced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent exposures. The most common symptoms are skin rash or anaphylaxis.

5 Humira 5 Active psoriatic arthritis (PsA) Initial authorization of 6 months may be granted for members who meet the following criteria: Member has been diagnosed with active PsA, and meets ANY of the following: Member experienced an inadequate response to methotrexate Member has a history of intolerance to methotrexate Member has a contraindication to methotrexate Active ankylosing spondylitis (AS) and axial spondyloarthritis Initial authorization of 6 months may be granted for members with active AS/axial spondyloarthritis who meet ANY of the following criteria: Member has experienced an inadequate response to treatment with an NSAID over a 4-week period in total at the maximum recommended or tolerated anti-inflammatory dose Member has experienced intolerance to NSAID therapy Member has a contraindication to all NSAIDs 7. Active polyarticular juvenile idiopathic arthritis (pjia) Initial authorization of 6 months may be granted for members with active pjia who have tried a disease modifying anti-rheumatic drug (DMARD). 8. Hidradenitis suppurativa Initial authorization of 6 months may be granted for members who have moderate to severe hidradenitis suppurative that is refractory to standard first-line treatment (eg, antibiotics). 9. Uveitis Initial authorization of 6 months may be granted for members who have non-infectious intermediate, posterior or panuveitis. E.D. CONTINUATION OF THERAPY 1. No previous authorization/precertification: All members (including new members and members currently receiving treatment without prior authorization) must meet criteria for initial approval in section C. 2. Reauthorization: Authorization for members who have had Humira previously authorized by HMSA/CVS are subject to the continuation criteria below for approval. b.a. Chronic pplaque ppsoriasis To receive aauthorization offor an additional 6 months may be granted to members requesting authorization for continuation of therapy who are benefitting from Humira therapy as evidenced by of therapy for chronic plaque psoriasis, documentation supporting a decrease in percent of body surface area involvement when compared to baseline must be submitted, and were previously authorized by HMSA/CVS. Thereafter, authorization of 12 months may be granted. c.b. Crohn s ddisease Authorization of an additional 12 months may be granted to members requesting authorization for continuation of therapy who have For members receiveding 6 to 12 months of treatment with Humira for Crohn s disease,and are benefitting from Humira therapy a positive clinical response to treatment as evidenced by a decreased or stable CDAI scoreseverity of condition compared with baseline, is required and were previously

6 Humira 6 authorized by HMSA/CVS. Thereafter, authorization of an additional 12 months may be granted. d.c. All oother iindications Authorization of an additional 12 months may be granted for members for all other indicationsrequesting authorization for continuation of therapy who achieve or maintain positive clinical responseare benefitting from Humira therapy as evidenced by low disease activity, improvement in signs and symptoms or maintenance of improvement in signs and symptoms, and were previously authorized by HMSA/CVS. F.E. DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. G.F. ADMINISTRATIVE GUIDELINES Precertification is required. Please refer to the HMSA medical policy web site for the fax form. H.G. IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA/CVS s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. I.H. REFERENCES 1. Humira [package insert]. North Chicago, IL: AbbVie Inc.; DecemberOctober van der Heijde D, Sieper J, Maksymowych WP, et al Update of the international ASAS recommendations for the use of anti-tnf agents in patients with axial spondyloarthritis. Ann Rheum Dis. 2011;70: Sieper J, van der Heijde D, Dougados M, et al. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomized placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013;72(6): Sotiriou E, Apalla Z, Vakirlis E, et al. Efficacy of adalimumab in recalcitrant hidradenitis suppurativa. Eur J Derm. 2009;19(2): Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Rheum Dis. 2014;73:

7 Humira 7 6. Singh JA, Furst DE, Bharat A, et al Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res 2012;64(5): Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6): Aletasha D, Neogi T, Silman AJ, et al Rheumatoid Arthritis Classification Criteria. An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis Rheum. 2010;62: Anderson J, Caplan L, Yazdany J, et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Rheum. 2010;64: Beukelman T, Patkar NM, Saag KG, et al American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011;63(4): Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 2012;71: Gladman DD, Antoni C, P Mease, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14 ii Peluso R, Lervolino S, Vitiello M, et al. Extra-articular manifestations in psoriatic arthritis patients. Clin Rheumatol May 8. [Epub ahead of print]. 14. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1): Braun J, van den Berg R, Baraliakos X, et al update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70: Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25. Document History 10/01/2015 Original effective date 12/2015 Revision 04/2016 Revision 06/2016 Revision 07/2016 Added new FDA-approved indication 08/01/2016 Revision effective date 12/2/2016 Annual review 12/30/2016 Revision effective date 08/2017 Annual Review 03/01/2018 Revision Effective Date 03/2018 Annual review 11/01/2018 Revision effective date